QUANTA LITE B2 GPI IGA

FDA 510(k)

FDA Class 2 ·Immunology

INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

READMYHEART, MODEL RMH2.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

READMYHEART, MODEL RMH3.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

Surgical Face Mask (HNFM0304)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Face Mask (HNFM0103)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

e-SDF

FDA 510(k)

FDA Class 2 ·Dental

Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

FDA classification

FDA Class 2 ·System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Radioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep.

FDA classification

FDA Class 2 ·Radioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep.

NIRO-200NX

FDA 510(k)

FDA Class 2 ·Cardiovascular

P300 Attachment

FDA 510(k)

FDA Class 2 ·Neurology

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5

FDA 510(k)

FDA Class 2 ·Radiology

Estelite Universal Flow

FDA 510(k)

FDA Class 2 ·Dental

FUJIFILM Endoscope Model EG-530N

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XIDF-AWS801, Angio Workstation, V7.0

FDA 510(k)

FDA Class 2 ·Radiology